A Phase II Trial of Adjuvant Radiotherapy Combined With Chemotherapy for Patients With High-risk Endometrial Cancer

NCT ID: NCT01918124

Last Updated: 2018-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2014-01-31

Brief Summary

This phase II clinical trial was designed to assess the feasibility, safety, toxicity, recurrence and survival pattern when TP or CAP chemotherapy was combined with adjuvant radiation for patients with high-risk endometrial cancer.

Conditions

Prosthesis Survival

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

radiotherapy combined with chemotherapy

Arm Label: radiotherapy combined with chemotherapy:

Radiotherapy:

Pelvic radiation to 45 Gy, 1.8 Gy per day, five days per week (25 fractions) or intensive modulated pelvic radiotherapy, with brachytherapy boost to the vagina if total abdominal hysterectomy and bilateral salpingo-oophorectomy was done in surgery, or with paraaortic radiation if paraaortic lymphnode metastases were found after surgery.

Cisplatin:

Two courses cisplatin (50mg/m2) given on days 1 and 28 during radiotherapy.

Cisplatin and Doxorubicin and Cyclophosphamide： Four courses of cisplatin (50mg/m2) and doxorubicin (60mg/m2) and cyclophosphamide (600mg/m2) given at 3 week intervals following completion of radiotherapy.

Paclitaxel and Carboplatin： Or four courses of Paclitaxel(135mg/m2) and carboplatin (AUC=5) given at 3 week intervals following completion of radiotherapy.

Group Type: EXPERIMENTAL

radiotherapy

Intervention Type: RADIATION

Pelvic radiation to 45 Gy, 1.8 Gy per day, five days per week (25 fractions) or intensive modulated pelvic radiotherapy, with brachytherapy boost to the vagina if total abdominal hysterectomy and bilateral salpingo-oophorectomy was done in surgery, or with paraaortic radiation if paraaortic lymphnode metastases were found after surgery.

Cisplatin

Intervention Type: DRUG

Two courses cisplatin (50mg/m2) given on days 1 and 28 during radiotherapy.

Cisplatin and Doxorubicin and Cyclophosphamide

Intervention Type: DRUG

Four courses of cisplatin (50mg/m2) and doxorubicin (60mg/m2) and cyclophosphamide (600mg/m2) chemotherapy given at 3 week intervals following completion of radiotherapy.

Paclitaxel and Carboplatin

Intervention Type: DRUG

Or four courses of Paclitaxel(135mg/m2) and carboplatin (AUC=5) given at 3 week intervals following completion of radiotherapy.

Interventions

radiotherapy

Pelvic radiation to 45 Gy, 1.8 Gy per day, five days per week (25 fractions) or intensive modulated pelvic radiotherapy, with brachytherapy boost to the vagina if total abdominal hysterectomy and bilateral salpingo-oophorectomy was done in surgery, or with paraaortic radiation if paraaortic lymphnode metastases were found after surgery.

Intervention Type: RADIATION

Cisplatin

Two courses cisplatin (50mg/m2) given on days 1 and 28 during radiotherapy.

Intervention Type: DRUG

Cisplatin and Doxorubicin and Cyclophosphamide

Four courses of cisplatin (50mg/m2) and doxorubicin (60mg/m2) and cyclophosphamide (600mg/m2) chemotherapy given at 3 week intervals following completion of radiotherapy.

Intervention Type: DRUG

Paclitaxel and Carboplatin

Or four courses of Paclitaxel(135mg/m2) and carboplatin (AUC=5) given at 3 week intervals following completion of radiotherapy.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients must have had a hysterectomy (total abdominal, vaginal hysterectomy, or laparoscopic-assisted vaginal hysterectomy) or modified radical hysterectomy or radical hysterectomy and bilateral salpingo-oophorectomy no more than 8 weeks prior to start of radiation therapy.

Additional surgical staging procedures are permissible but not required.

• Risk factors: patients must fit one of the following:

• Pelvic lymph node metastases
• Paraaortic lymph node metastases
• Grade 3 with myometrial invasion >50%
• With stromal invasion of cervix
• Known extrauterine disease (excluding second primary) confined to the pelvis.
• High risk pathological type include: uterine papillary serous carcinoma, clear cell carcinoma, squamous cell carcinoma, undifferentiated carcinoma,
• No known gross residual disease, or distant metastases.
• Eastern Cooperative Oncology Group (ECOG) score<=2; Age 18~75.
• White Blood Cell (WBC)≥4000/mm3, granulocytes ≥1500/mcl, platelets≥100,000/mcl.
• Acceptable hepatic and renal function: creatinine <=1.4 mg%, bilirubin and serum glutamate oxaloacetate transaminase (SGOT) <=2*normal.
• No medical contraindications to chemotherapy, or radiation therapy.
• Study-specific signed informed consent.

Exclusion Criteria

• Prior pelvic radiation therapy.
• Positive peritoneal cytology only for stage IIIa (FIGO 1998).
• With history of other malignancies less than 5 years.
• With gross residual disease, or distant metastases.
• With endometrioid endometrial carcinoma and no risk factors:

• with myometrial invasion <50%
• Grade 1~2, with myometrial invasion >50%
• With serious internal diseases which affect designed treatment
• With psychotic disorders

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fan Ming

OTHER

Sponsor Role: lead

Responsible Party

Fan Ming

Shanghai Cancer Center

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Huaying Wang, Doctor

Role: STUDY_CHAIR

Shanghai Cancer Center

Locations

Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Countries

China

References

Ren Y, Huang X, Shan B, Wu X, Huang X, Shi D, Wang H. Adjuvant concurrent chemoradiation followed by chemotherapy for high-risk endometrial cancer. Gynecol Oncol. 2016 Jan;140(1):58-63. doi: 10.1016/j.ygyno.2015.11.021. Epub 2015 Nov 24.

Reference Type: DERIVED

PMID: 26607778 (View on PubMed)

Related Links

http://www.shca.org.cn

Related Info

Other Identifiers

070148-7

Identifier Type: -

Identifier Source: org_study_id